Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-07-31

Brief Summary

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Single centre, open-label, randomised study in four parallel groups of healthy volunteers

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Detailed Description

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Single centre, open-label, randomised study in four parallel groups of healthy volunteers: Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093); Group 2 = 450 mg of S-licarbazepine plus 450 mg of R-licarbazepine; Group 3 = 450 mg of S-licarbazepine; Group 4 = 450 mg of Rlicarbazepine. In each group, the study consisted of a single-dose period (Phase A) followed by a repeateddose period of 7 days of duration in which the investigational product was administered once daily (Phase B). The repeated-dose phase started 96 h post single-dose.

Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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eslicarbazepine acetate

900mg of eslicarbazepine acetate (ESL, BIA 2-093)

Group Type EXPERIMENTAL

BIA 2-093

Intervention Type DRUG

Tablets containing 900 mg

S-licarbazepine R-licarbazepine

450 mg of S-licarbazepine plus 450 mg of R-licarbazepine

Group Type ACTIVE_COMPARATOR

S-licarbazepine

Intervention Type DRUG

capsules containing 225 mg

R-licarbazepine

Intervention Type DRUG

capsules containing 225 mg

S-licarbazepine

450 mg of S-licarbazepine

Group Type ACTIVE_COMPARATOR

S-licarbazepine

Intervention Type DRUG

capsules containing 225 mg

R-licarbazepine

450 mg of Rlicarbazepine

Group Type ACTIVE_COMPARATOR

R-licarbazepine

Intervention Type DRUG

capsules containing 225 mg

Interventions

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BIA 2-093

Tablets containing 900 mg

Intervention Type DRUG

S-licarbazepine

capsules containing 225 mg

Intervention Type DRUG

R-licarbazepine

capsules containing 225 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects aged between 18 and 45 years, inclusive.
* Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
* Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.
* Subjects who had clinical laboratory tests clinically acceptable at screening and admission.
* Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.
* Subjects who were negative for drugs of abuse and alcohol at screening and admission.
* Subjects who were non-smokers or who smoke \< 10 cigarettes or equivalent per day.
* Subjects who are able and willing to give written informed consent.
* (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
* (If female) She had a negative pregnancy test at screening and admission to Phase A.

* Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
* Subjects who had a clinically relevant surgical history.
* Subjects who had a clinically relevant family history.
* Subjects who had a history of relevant atopy.
* Subjects who had a history of relevant drug hypersensitivity (especially carbamazepine or oxcarbazepine).
* Subjects who had a history of alcoholism or drug abuse.
* Subjects who consumed more than 14 units of alcohol a week.
* Subjects who had a significant infection or known inflammatory process on screening or admission.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes